Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).

Key facts

Study ID

NCT04770714

Run by

University of Arizona

People needed

0

Starts

2021-01-19

Expected to finish

2025-01-01

Last updated by the study team

2024-02-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery
• Clinically indicated referral for breast MRI or contrast mammogram prior to surgery
• Provision of informed consent

You may not qualify if…

• Planned neoadjuvant chemotherapy
• Patients that are medically unstable
• Pregnancy
• Patients with known contraindication to contrast mammography, including:
• Glomerular filtration rate <30
• Known adverse reaction to iodinated contrast material
• Patients with known contraindication to Breast MRI including:
• Glomerular filtration rate <30
• Known adverse reaction to gadolinium contrast material
• Non-MRI conditional device or catheter
• Brain aneurysm clip implanted before 1995
• Cochlear implant
• Ocular foreign body (e.g. metal shavings)
• Insulin pump
• Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)

Where it is running

• Banner University Medical Center Phoenixq — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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